IKEMA: SARCLISA + CARFILZOMIB
AND DEXAMETHASONE (Kd)

IKEMA Trial: SARCLISA
+ Kd vs Kd Alone

Watch the snapshot summary of how
SARCLISA was studied

See how SARCLISA was studied in two phase 3 trials that included lenalidomide-refractory patients1

Evaluated in 302 patients in a phase 3, multicenter, multinational, randomized, open-label study1,2

Patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy (N=302)
Randomized 3:2

sarclisaa + Kdb
(n=179)

Kdb
(n=123)

Treatment was administered in 28-day cycles until disease progression or unacceptable toxicity.

aSARCLISA 10 mg/kg was administered as an IV infusion weekly in the first cycle and every 2 weeks thereafter.

bCarfilzomib was administered as an IV infusion during cycle 1 at a dose of 20 mg/m2 on days 1 and 2, and at 56 mg/m2 on days 8, 9, 15, and 16; during subsequent cycles, it was administered at 56 mg/m2 on days 1, 2, 8, 9, 15, and 16. Dexamethasone (IV on the days of SARCLISA and/or carfilzomib infusions, and orally on the other days) 20 mg was given on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.

primary endpoint: PFS*

Key secondary endpoints: ORR, ≥VGPR, CR, MRD negativity, OS

*PFS results were assessed by an independent response committee, based on central laboratory data for monoclonal protein, and central radiologic imaging review using the International Myeloma Working Group criteria. An interim analysis was conducted when 65% of the 159 PFS events (ie, 103 events) were observed. A prespecified final analysis was conducted when 159 PFS events were observed, with a median follow-up of 44 months.1-3 CR=complete response; IV=intravenous; MRD=minimal (or measurable) residual disease; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; VGPR=very good partial response.

The IKEMA trial included a broad and diverse patient population1,2,4

Patient factors

28%
≥70 years of age
20%
Impaired renal functiona
24%
High cytogenetic risk

Treatment history

90%/43%
Prior PI/lenalidomide
33%
Refractory to lenalidomide
61%
Prior ASCT

Baseline characteristics were similar across both treatment arms

Baseline characteristics
SARCLISA + Kd
(n=179)
Kd
(n=123)
Age, years
 
 
Median (range)
65 (37-86)
63 (33-90)
<70
71%
72%
≥70
29%
28%
Renal impairmenta
 
 
≥60 mL/min/1.73 m2
68%
76%
<60 mL/min/1.73 m2
24%
15%
≥15-<30 mL/min/1.73 m2
2%
2%
ECOG PS
 
 
0 or 1
94%
96%
2
6%
4%
ISS stage at study entry
I
50%
58%
II
35%
25%
III
15%
16%
Cytogenetic abnormality at baseline
Highb
23%
25%
    del(17p)
10%
13%
    t(4;14)
12%
16%
    t(14;16)
3%
0%
Standard
64%
63%
Unknown or missing
13%
11%
1q21+c
42%
42%
Prior lines of therapyd
 
 
Median (range)
2 (1-4)
2 (1-4)
1
44%
45%
Prior therapies
 
 
PI
93%
85%
IMiD
76%
81%
Lenalidomide
40%
48%
Patient refractory to
 
 
IMiD
44%
47%
Lenalidomide
32%
34%
IMiD + PI
20%
22%
Previous ASCT
 
 
Yes
65%
56%

aImpaired renal function is defined as eGFR <60 mL/min/1.73 m2.1

bHigh-risk cytogenetic status is defined as the presence of del(17p) and/or t(4;14) and/or t(14;16). Chromosomal abnormality was considered positive if present in ≥30% of analyzed plasma cells, except for del(17p), where the threshold is ≥50%.2

c1q21+ was also analyzed and was considered positive if there were ≥3 copies in ≥30% of analyzed plasma cells.2

dInclusion criteria for the IKEMA study specified 1 to 3 prior lines of therapy; however, 3 patients (1.7%) and 2 patients (1.6%) had >3 prior lines in the SARCLISA + Kd and Kd arms, respectively.2

Explore a patient case with high-risk factors who may be
appropriate for SARCLISA + Kd at first relapse1

ASCT=autologous stem cell transplant; ECOG PS=Eastern Cooperative Oncology Group performance status; eGFR=estimated glomerular filtration rate; IMiD=immunomodulatory drug; ISS=International Staging System; PI=proteasome inhibitor.

IKEMA Trial Results